Requirements for medical devices

Do you manufacture medical devices or do you introduce them onto the European market? Do you sell medical devices, for instance in a wholesale business, pharmacy, or drugstore? Or are you, for example, a doctor, physiotherapist, or cosmetologist and do you use medical devices in the treatment of patients? Medical devices must meet the legal requirements and must be safe for patients. You must register your medical devices in the European Database on Medical Devices (EUDAMED).

The Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd, IGJ) is the supervisory body for medical devices.

What are medical devices?

Medical devices are products used for diagnoses and treatments in the healthcare sector, or products that can help prevent or predict diseases or disorders. For example:

• surgical instruments
• breast implants
• pacemakers
• wheelchairs
• software (for example medical apps)

If you are not sure if your product is a medical device, the European Medicine Agency (EMA) provides an overview of what products are considered medical devices.

Risk classes of medical devices

Medical devices are classified according to risk. The more risk there is for the patient, the stricter the inspections are to assess if a medical device will be allowed onto the market. There are 4 categories:

• class I medical devices with low risk (examples are adhesive bandages, glasses, wheelchairs)
• class IIa medical devices with moderate risk (for example dental fillings, surgical clamps)
• class IIb medical devices with moderate to high risk (for example anaesthesia machines)
• class III medical devices that come into direct contact with the heart, the central circulatory system, or the central nervous system (for example cardiac catheters and contraceptive coils)

You can check how devices are qualified in Annex VIII of the European Medical Devices Regulation (MDR).

Risk classes of in vitro diagnostics (IVDs)

In vitro diagnostics (IVDs) are a separate type of medical devices. They are used to examine samples from body materials, such as urine tests, pregnancy tests, or blood glucose meters.

The risk classes for IVDs are:

• A: low risk (such as container for specimens, prepared selective media)
• B: medium risk (for example pregnancy test, cholesterol self-test)
• C: medium to high risk (such as blood glucose self-test, genetic testing)
• D: high risk (for example Hepatitis B blood donor test, HIV diagnostic blood test)

You can check how IVDs are classified in Annex VIII of the European In Vitro Diagnostic medical devices Regulation (IVDR).

Registering in EUDAMED

As a manufacturer, importer, or authorised representative of medical devices and in vitro diagnostics, you must register in EUDAMED (European Database on Medical Devices). You must do this before marketing a medical device. An authorised representative must meet several requirements.

As an importer, you must check that the manufacturer and/or authorised representative has registered everything correctly in EUDAMED. As a distributor, you must check that the importer meets the requirements.

Registering medical devices

You must register your medical devices in EUDAMED before you introduce them onto the European market. In some cases, you have to notify medical devices in risk class I and all IVDs in NOTIS, the Dutch database of medical devices. You must always register custom-made medical devices in NOTIS, except if the medical device is a class III implantable custom-made device, then you must register the device in EUDAMED.

If you make any changes to your medical device or IVD, you must note these changes in the database. If you no longer supply the product, you must deregister it.

Mandatory Unique Device Identifier

Each medical device must have a unique identification code (UDI) for identification and traceability purposes. As a manufacturer, you must place the UDI on the device label or on the device itself, and on the packaging, with a readable code, QR code, or bar code. And you must register the UDI in EUDAMED. Custom-made medical devices do not require a UDI. As an importer or distributor, you must check if the medical device has a UDI.

Clinical evaluation and technical file

Before you market a medical device, you must investigate whether the product is safe to use and works as intended. It depends on the risk class of your medical device or whether you need to conduct a clinical investigation or a performance study.

You must submit a clinical investigation with a medical device to the Central Committee on Research Involving Human Subjects (Centrale Commissie Mensgebonden Onderzoek, CCMO). You must also submit a performance study with an IVD to CCMO in many cases.

You must create a technical file containing the technical specifications of the device and the results of the clinical evaluations.

CE marking

Every medical device on the European market must have CE marking. CE marking means your product complies with the legal requirements.

The following medical devices must be inspected by an independent authority (notified body):

• medical devices Class IIa, IIb, and III
• IVDs Class B, C, and D
• medical devices Class I which are sterile, have a measuring function, or which are reusable surgical instruments

If the notified body approves the product, you must put the CE marking on your device. Only then are you allowed to market the medical device. The notified body must register information about the given certificates in EUDAMED .

For Class I and A medical devices you assess if the product complies with the Medical Devices Regulation yourself. If this is the case, you may put the CE marking on the product.

You are not allowed to market, import, sell, or use medical devices without a CE marking. Custom-made medical devices do not have a CE marking.

Labelling and instructions for use

As a manufacturer, you must provide clear labelling and instructions for use for medical devices and IVDs, so the patient can use the device safely and correctly. In the Netherlands, the information on labels and instructions for use must be in Dutch. The address of the manufacturer must be stated on the label. If the manufacturer is from outside the EU, the address of the authorised representative must also be on the label.

As an importer, you must put your registered (trade) name or brand name, your place of business and your address on the device, its packaging, or in a document that you include with the device. You must check that the correct label and instructions for use are present.

As a distributor, you must check that the correct label and instructions for use are present.

For medical devices in risk class I or IIa an instruction for use is not necessary if the patient can safely use it without instructions.

Keep track of the medical device (post-market surveillance)

As the manufacturer or representative, you remain responsible for your product. You must keep track of it (post-market surveillance, PMS) and improve it, if necessary. You must handle complaints and reports about the product, and you must ask users for information about the product's quality and performance. You must draw up a post-market surveillance plan (PMS plan) which explains how you will do this, and a periodic safety update report (PSUR) with the results and conclusions of the analyses. This allows you to intervene faster when things go wrong and further improve the medical device.

Are you the importer or distributor and did you receive a complaint or report about a product you imported or sold? Or do you suspect that a product does not meet all requirements? If so, you must inform the manufacturer, the authorised representative, and/or the importer immediately. If a medical device presents a serious risk, you must also report this to the inspectorate.

As an importer, you must keep a register of complaints, recalled and withdrawn devices, and devices that do not meet the requirements.

Reporting incidents and changes

If you are a manufacturer or representative and there is an incident in which your medical device is involved, you must notify the inspectorate. You must also notify the inspectorate if you correct an issue with the product (Field Safety Corrective Action, FSCA), for instance, if you recall it or if you change the design, instruction, or packaging. You must also include this in your reporting system.

Set up a quality management system

Are you a manufacturer? You must set up a quality management system. This includes, among others, your risk management, clinical evaluation, post-market surveillance system, and the processes for reporting of serious incidents.

Extra rules for implants

For implants, such as artificial hip joints, artificial cardiac pacemakers, or breast implants, extra rules apply. Manufacturers must supply an implant card, with information about the implant itself and the manufacturer.

If you supply implants directly to patients, you need to state the patient’s details on the implant card and record the implant data in the patient's electronic patient record (EPR) (in Dutch). The implants must be registered in the Dutch National Implants Registry (Landelijk Implantaten Register, LIR, in Dutch). You must do this within 1 month.

You must report side effects of implants to the Dutch Reporting Centre for Adverse Effects of Medical Implants (Meldpunt en Expertisecentrum Bijwerkingen Implantaten, MEBI, in Dutch).

Report supply interruptions of medical devices and IVD’s

If you (temporarily) stop supplying a device as a manufacturer, you must notify your customers. You must also notify the national reporting centre for supply interruptionsMeldpunt Leveringsonderbrekingen Medische Hulpmiddelen (in Dutch). You must do this at least 6 months before the supply is interrupted, or as soon as possible.

As a manufacturer, distributor, or healthcare institution, you also must report the expected supply interruption to the Healthcare Procurement Network Netherlands (Zorg Inkoop Netwerk Nederland, in Dutch).

Reprocessing of single-use medical devices

Manufacturers and healthcare institutions are allowed to reprocess single-use medical devices. Only healthcare institutions may outsource it to an external party. Do you reprocess single-use medical devices, for example by cleaning, disinfecting, or sterilising it? You must follow the national rules. Note that not all single-use devices may be reprocessed (in Dutch).

Self-made medical devices

Do you make medical devices in your healthcare institutions and do you use them only there, fewer rules apply than for manufacturers, if you meet the conditions.